Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
Brief summary
The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to patients with advanced or metastatic non-small cell lung cancer.
Detailed description
GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.
Interventions
The starting dose of GRN163L for this study will be 3.2 mg/kg. Subsequent dose levels will be 4.8, 6, 7.5, 9, 11, and 13.5 mg/kg. The maximum dose to be administered will not exceed 13.5 mg/kg. Paclitaxel and carboplatin will be administered on Day 2 of each 21-day cycle.
Sponsors
Geron Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of NSCLC * Stage IIIb with pleural effusion, Stage IV, or recurrent disease * Measurable or evaluable disease by RECIST criteria * ECOG performance status 0-1 * Adequate hepatic/renal function and platelet count * If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50%
Exclusion criteria
* More than 2 prior chemotherapy regimens for metastatic disease (prior adjuvant chemotherapy is allowed) * Tumor progression during treatment with paclitaxel (refractory to paclitaxel) * Taxane-based regimen within 12 weeks * Any systemic therapy for cancer within 4 weeks * Anti-platelet therapy within 2 weeks, other than low dose aspirin prophylaxis therapy * Therapeutic anticoagulation therapy except for low dose warfarin (eg, 1 mg by mouth per day) * Radiation therapy within 3 weeks * Major surgery within 4 weeks (central line placement is allowed) * Prolongation of PT or aPTT \> the ULN or fibrinogen \< the LLN * History of or active central nervous system metastatic disease * Any other active malignancy * Active or chronically recurrent bleeding (eg, active peptic ulcer disease) * Clinically significant infection * Active autoimmune disease requiring immunosuppressive therapy * Clinically significant cardiovascular disease or condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and MTD | First 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| PK and efficacy | Baseline to end of treatment |
Countries
United States
Outcome results
None listed